Device
els extra low shrinkage® composite (els composite for short) is a light-curing, highly filled, radiopaque micro hybrid composite with extremely
Manufacturer
Saremco Dental AG
Model: A3 Catalog: 7101 DI: D93171011 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
els extra low shrinkage® composite (els composite for short) is a light-curing, highly filled, radiopaque micro hybrid composite with extremely low shrinkage stress for permanent anterior and posterior restorations. els extra low shrinkage® composite is a polymer-based restorative material, Type 1, Class 2, Group 1 and 2 according to DIN EN ISO 4049
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 01f9a793-d2b6-422f-9275-55ad9bf26afd
Distribution Status: In Commercial Distribution
DUNS Number: 480619001
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: D93171011
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 35870
Name: Dental composite resin
Definition:
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
FDA Product Codes
EBF
Material, Tooth Shade, Resin
Premarket Submissions
Submission Number: K240823
Supplement Number: 000